Diffuse Midline Glioma, H3 K27M-MutantNCT05518838
Expanded Access to OKN-007 for Patients With Diffuse Midline Glioma, H3 K27-altered
A study testing OKN-007 in people with Diffuse Midline Glioma, H3 K27M-Mutant and Diffuse Intrinsic Pontine Glioma, run by Oblato, Inc. at 9 sites in United States.
Trial summary
To provide OKN-007 for compassionate use in patients with diffuse midline glioma, H3 K27-altered (DMG), including diffuse intrinsic pontine glioma (DIPG), pediatric and young adult patients with high-grade diffuse midline glioma will be treated under this Intermediate-sized expanded access treatment protocol. Read more about this study
- Who is it for?
- Ages 13 months to 18 years
- Conditions the study is for
- Diffuse Midline Glioma, H3 K27M-Mutant, Diffuse Intrinsic Pontine Glioma
- What is being tested?
- OKN-007
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- 9 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 months to 18 years
- All sexes
- Child, Adult
Who may be able to join
- Age from > 12 months to ≤ 18 years of age at the time of enrollment.
- Diagnosis of diffuse midline glioma, H3 K27-altered according to the WHO 2021 Classification of Tumors of the Central Nervous System diagnostic criteria including diffuse intrinsic pontine glioma (DIPG). In the absence of a pathologically confirmed diagnosis, a grade IV glioma involving the thalamus, hypothalamus, brainstem, cerebellum, midbrain, or spinal cord, or with a pontine epicenter and diffuse involvement of the pons.
- Patient has completed definitive radiation therapy as part of standard-of-care treatment or was unable to undergo radiation.
- Karnofsky performance status ≥ 50 for patients ≥ 16 years of age and Lansky performance status ≥ 50 for patients < 16 years of age; patients who are unable to walk because of paralysis, but who are upright in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
- Patients must have adequate bone marrow, liver, and renal function:
- For females of childbearing potential, negative urinary or serum pregnancy test.
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- Patients must be willing to highly effective contraception for both male and female patients throughout the treatment and for at least 4 months after last treatment administration.
- Toxicities related to any prior treatments are either stable, stable on supportive therapy, resolved, or in the opinion of the treating physician, clinically non-significant
- Ability to understand a written informed consent document, and the willingness to sign it. Assent will be obtained when appropriate based on the patient's age.
Who cannot join
- Patient is already participating in or qualifies for and is able to enroll in a clinical trial of OKN-007 and other ongoing clinical trials.
- Patient has received systemic therapy with an investigational agent within 5 half-lives or 14 days prior to starting OKN-007 treatment, whichever is shorter.
- Patients completing radiotherapy treatment less than 14 days prior to planned study treatment initiation.
- Current evidence of uncontrolled, significant intercurrent illness that would, in the treating physician's judgment, contraindicate the patient's treatment with OKN-007 due to safety concerns.
- Patients who, in the opinion of the treating physician, have not fully recovered from recent major surgery to a sufficient extent to tolerate treatment with OKN-007.
- Known hypersensitivity to OKN-007 or any component in its formulation.
- Patients taking prohibited medications as described in the current Investigator's Brochure.
- Patient is pregnant or actively breastfeeding.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Prisma Health Midlands Pediatric Hematology/Oncology
Columbia, South Carolina, 29203
Children's Health
Dallas, Texas, 75235
Arkansas Children's Research Institute
Little Rock, Arkansas, 72202
Nicklaus Children's Hospital
Miami, Florida, 33155
Children's Hospital of The King's Daughters
Norfolk, Virginia, 23507
Children's Hospital and Medical Center
Omaha, Nebraska, 68114
Arnold Palmer Hospital for Children
Orlando, Florida, 32806
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, 24014
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, 33701
About this study
To provide OKN-007 for compassionate use in patients with diffuse midline glioma, H3 K27-altered (DMG), including diffuse intrinsic pontine glioma (DIPG), pediatric and young adult patients with high-grade diffuse midline glioma will be treated under this Intermediate-sized expanded access treatment protocol.
- Being tested
- OKN-007
- Medical subject headings
- Diffuse Intrinsic Pontine Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OKN-007Drug
OKN-007 is an intravenously administrated drug being developed as a novel anti-cancer therapy against gliomas.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Midline Glioma, H3 K27M-MutantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Oblato, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05518838
- Sponsor's protocol ID
- OKN-007-EA-DMG
- Status last verified
- Nov 2024
- First submitted
- 24 Aug 2022
- Last updated
- 8 Nov 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access to OKN-007 for Patients With Diffuse Midline Glioma, H3 K27-altered
- ClinicalTrials.gov ID
- NCT05518838
- Acronym / sponsor ID
- OKN-007-EA-DMG
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Oblato, Inc.Industry (pharma, biotech, devices)
- First posted
- 29 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To provide OKN-007 for compassionate use in patients with diffuse midline glioma, H3 K27-altered (DMG), including diffuse intrinsic pontine glioma (DIPG), pediatric and young adult patients with high-grade diffuse midline glioma will be treated under this Intermediate-sized expanded access treatment protocol.
Study design
Who may qualify
- Ages
- 13 months to 18 years
- Sex
- All
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Age from > 12 months to ≤ 18 years of age at the time of enrollment.
- Diagnosis of diffuse midline glioma, H3 K27-altered according to the WHO 2021 Classification of Tumors of the Central Nervous System diagnostic criteria including diffuse intrinsic pontine glioma (DIPG). In the absence of a pathologically confirmed diagnosis, a grade IV glioma involving the thalamus, hypothalamus, brainstem, cerebellum, midbrain, or spinal cord, or with a pontine epicenter and diffuse involvement of the pons.
- Patient has completed definitive radiation therapy as part of standard-of-care treatment or was unable to undergo radiation.
- Karnofsky performance status ≥ 50 for patients ≥ 16 years of age and Lansky performance status ≥ 50 for patients < 16 years of age; patients who are unable to walk because of paralysis, but who are upright in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
- Patients must have adequate bone marrow, liver, and renal function:
Key exclusion criteria (8 listed)
- Patient is already participating in or qualifies for and is able to enroll in a clinical trial of OKN-007 and other ongoing clinical trials.
- Patient has received systemic therapy with an investigational agent within 5 half-lives or 14 days prior to starting OKN-007 treatment, whichever is shorter.
- Patients completing radiotherapy treatment less than 14 days prior to planned study treatment initiation.
- Current evidence of uncontrolled, significant intercurrent illness that would, in the treating physician's judgment, contraindicate the patient's treatment with OKN-007 due to safety concerns.
- Patients who, in the opinion of the treating physician, have not fully recovered from recent major surgery to a sufficient extent to tolerate treatment with OKN-007.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OKN-007OKN-007 is an intravenously administrated drug being developed as a novel anti-cancer therapy against gliomas. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OKN-007 in people with Diffuse Midline Glioma, H3 K27M-Mutant and Diffuse Intrinsic Pontine Glioma, run by Oblato, Inc. at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2024.